Nicotine

Product NDC: 0536-1108
11-digit product format: 005361108
Labeler code: 0536
Product ID: 0536-1108_4db08daa-369f-52ce-4876-e03455838521
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Rugby Laboratories
Application: NDA020076
Marketing category: NDA
Marketing start: 2016-04-01
Substance: NICOTINE
Active strength: 21 mg/24h
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020076-004	HABITROL	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12
N020076-005	HABITROL	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12
N020076-006	HABITROL	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1999-11-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020076-004	HABITROL	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020076-005	HABITROL	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020076-006	HABITROL	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1999-11-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020076-004	HABITROL	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020076-005	HABITROL	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020076-006	HABITROL	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1999-11-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020076-004	HABITROL	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020076-005	HABITROL	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020076-006	HABITROL	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1999-11-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020076-004	HABITROL	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020076-005	HABITROL	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020076-006	HABITROL	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1999-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020076-004	HABITROL	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020076-005	HABITROL	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020076-006	HABITROL	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1999-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020076-004	HABITROL	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020076-005	HABITROL	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020076-006	HABITROL	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1999-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020076-004	HABITROL	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020076-005	HABITROL	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020076-006	HABITROL	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1999-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020076-004	HABITROL	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020076-005	HABITROL	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020076-006	HABITROL	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1999-11-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020076-004	HABITROL	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020076-005	HABITROL	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020076-006	HABITROL	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1999-11-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020076-004	HABITROL	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020076-005	HABITROL	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020076-006	HABITROL	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1999-11-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020076-004	HABITROL	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020076-005	HABITROL	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020076-006	HABITROL	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1999-11-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020076-004	HABITROL	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020076-005	HABITROL	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020076-006	HABITROL	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1999-11-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020076-004	HABITROL	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020076-005	HABITROL	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020076-006	HABITROL	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1999-11-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020076-004	HABITROL	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1999-11-12	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nicotine
Brand name suffix: transdermal system step 1
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NICOTINE	21 mg/24h

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6M3C89ZY6R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198029	Internal RxNorm lookup
198030	Internal RxNorm lookup
198031	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ae406389-0f83-d5c8-bd2f-56075e57453a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0536-1108-88	2024-01-30	C162847	48780-1	1030e365-6a83-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0536-1108-52	Nicotine transdermal system step 1	24 h in 1 PATCH	PATCH, EXTENDED RELEASE	24	11
0536-1108-52	Nicotine transdermal system step 1	7 in 1 CARTON	PATCH, EXTENDED RELEASE	7	11
0536-1108-71	Nicotine transdermal system step 1	24 h in 1 PATCH	PATCH, EXTENDED RELEASE	24	11
0536-1108-71	Nicotine transdermal system step 1	28 in 1 CARTON	PATCH, EXTENDED RELEASE	28	11
0536-1108-88	Nicotine transdermal system step 1	24 h in 1 PATCH	PATCH, EXTENDED RELEASE	24	11
0536-1108-88	Nicotine transdermal system step 1	14 in 1 CARTON	PATCH, EXTENDED RELEASE	14	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-1108-88	EA - Each	0536-1108	9b5b1c28-0e9c-43ef-bf4c-4bf816be869e	1	2016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0536-1108	NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [RUGBY LABORATORIES]	10	Current NDC, Legacy NDC, 6 package rows	20240726_ae406389-0f83-d5c8-bd2f-56075e57453a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine Transdermal System Patch Step 3	NICOTINE TRANSDERMAL SYSTEM PATCH	BluePoint Laboratories	4856e99a-badc-b957-e063-6294a90a8606	2026-07-10	Warnings	Exact identifier application applno (NDA): 020076 application number: NDA020076
Nicotine Transdermal System step 3	NICOTINE	AmerisourceBergen Drug Corporation	e51d2c09-a20f-eb9b-e3e4-013f3e488ab3	2026-07-01	Warnings	Exact identifier application applno (NDA): 020076 application number: NDA020076
Nicotine transdermal system step 3	NICOTINE	Rugby Laboratories	ae406389-0f83-d5c8-bd2f-56075e57453a	2026-03-25	Warnings	Exact identifier application applno (NDA): 020076 application number: NDA020076 ndc (product): 0536-1108
Nicotine Transdermal System step 3	NICOTINE	CARDINAL HEALTH 110, LLC. DBA LEADER	dbbed17b-8ad3-05fb-fb63-03fbb75eae05	2026-03-18	Warnings	Exact identifier application applno (NDA): 020076 application number: NDA020076
NICOTINE TRANSDERMAL SYSTEM	NICOTINE	A-S Medication Solutions	cfb56e3e-ac5d-4086-a5d3-23080844b3e1	2026-03-13	Warnings	Exact identifier application applno (NDA): 020076 application number: NDA020076
Nicotine transdermal system step 3	NICOTINE	Golden State Medical Supply, Inc.	7c83d507-7e8d-496c-bb9d-63abfa25c7a7	2025-04-17	Warnings	Exact identifier application applno (NDA): 020076 application number: NDA020076
Nicotine transdermal system step 3	NICOTINE	CVS Pharmacy	d51d5224-f5bf-2510-1fa0-c4bb454f8160	2024-12-01	Warnings	Exact identifier application applno (NDA): 020076 application number: NDA020076
Nicotine transdermal system step 3	NICOTINE	Strategic Sourcing Services LLC	6c0b5b5c-cc76-6e48-c364-4db0e081557d	2024-11-09	Warnings	Exact identifier application applno (NDA): 020076 application number: NDA020076
Nicotine transdermal system step 3	NICOTINE	Rite Aid Corporation	d2e32434-ec58-943e-dbeb-8e7331531595	2024-07-26	Warnings	Exact identifier application applno (NDA): 020076 application number: NDA020076
NICOTINE TRANSDERMAL	NICOTINE	Rite Aid Corporation	ae6027da-5c96-ed47-e1ae-e900fc0f72ce	2024-07-26	Warnings	Exact identifier application applno (NDA): 020076 application number: NDA020076
Nicotine transdermal system step 3	NICOTINE	The Kroger Co.	13cdd780-4196-685b-3cab-f9694a327618	2024-07-25	Warnings	Exact identifier application applno (NDA): 020076 application number: NDA020076
Habitrol Step 3	NICOTINE TRANSDERMAL SYSTEM PATCH	Dr. Reddy's Laboratories Inc.	051be7ae-6504-c2d8-7424-2e328e4fcfc2	2024-07-25	Warnings	Exact identifier application applno (NDA): 020076 application number: NDA020076
Nicotine transdermal system step 2	NICOTINE	Chain Drug Marketing Association INC	df1348cb-0d15-7e4b-921c-d8764c858e66	2024-07-25	Warnings	Exact identifier application applno (NDA): 020076 application number: NDA020076
Nicotine transdermal system	NICOTINE	Dr. Reddys Laboratories Inc.	e2391b29-9bac-fc09-f2a5-a3370bc4e2c3	2024-07-25	Warnings	Exact identifier application applno (NDA): 020076 application number: NDA020076
nicotine transdermal system	NICOTINE	Dr. Reddy's Laboratories Inc.	b9946e3c-80c9-3076-7c32-e2988ac07048	2024-07-25	Warnings	Exact identifier application applno (NDA): 020076 application number: NDA020076
Nicotine transdermal system step 1	NICOTINE	DOLGENCORP, LLC	81e55db2-897e-e567-5743-63179783291a	2024-07-25	Warnings	Exact identifier application applno (NDA): 020076 application number: NDA020076
Nicotine transdermal system step 3	NICOTINE	Walgreens Company	de471db4-b332-0490-198d-d35480272874	2024-07-25	Warnings	Exact identifier application applno (NDA): 020076 application number: NDA020076
Nicotine transdermal system step 3	NICOTINE	Dr. Reddy's Laboratories Inc.	3a68eb70-0548-fa6f-8b1c-375e8799f24f	2024-07-24	Warnings	Exact identifier application applno (NDA): 020076 application number: NDA020076
Nicotine transdermal system step 3	NICOTINE	A-S Medication Solutions	798a66fa-25d8-4713-b25f-56875431e37d	2023-03-02	Warnings	Exact identifier application applno (NDA): 020076 application number: NDA020076

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6M3C89ZY6R	NICOTINE	54-11-5	NICOTINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198029	nicotine 14 MG/Day 24HR Transdermal System	PSN	ae406389-0f83-d5c8-bd2f-56075e57453a	11
198030	nicotine 21 MG/Day 24HR Transdermal System	PSN	ae406389-0f83-d5c8-bd2f-56075e57453a	11
198031	nicotine 7 MG/Day 24HR Transdermal System	PSN	ae406389-0f83-d5c8-bd2f-56075e57453a	11
198031	24 HR nicotine 0.292 MG/HR Transdermal System	SCD	ae406389-0f83-d5c8-bd2f-56075e57453a	11
198029	24 HR nicotine 0.583 MG/HR Transdermal System	SCD	ae406389-0f83-d5c8-bd2f-56075e57453a	11
198030	24 HR nicotine 0.875 MG/HR Transdermal System	SCD	ae406389-0f83-d5c8-bd2f-56075e57453a	11
198031	nicotine 0.292 MG/HR 24HR Transdermal Patch	SY	ae406389-0f83-d5c8-bd2f-56075e57453a	11
198029	nicotine 0.583 MG/HR 24HR Transdermal Patch	SY	ae406389-0f83-d5c8-bd2f-56075e57453a	11
198030	nicotine 0.875 MG/HR 24HR Transdermal Patch	SY	ae406389-0f83-d5c8-bd2f-56075e57453a	11
198029	nicotine 14 MG per 24HR 1 Day Transdermal Patch	SY	ae406389-0f83-d5c8-bd2f-56075e57453a	11
198029	nicotine 14 MG/Day 24HR Transdermal System	SY	ae406389-0f83-d5c8-bd2f-56075e57453a	11
198030	nicotine 21 MG per 24HR 1 Day Transdermal Patch	SY	ae406389-0f83-d5c8-bd2f-56075e57453a	11
198030	nicotine 21 MG/Day 24HR Transdermal System	SY	ae406389-0f83-d5c8-bd2f-56075e57453a	11
198031	nicotine 7 MG per 24HR 1 Day Transdermal Patch	SY	ae406389-0f83-d5c8-bd2f-56075e57453a	11
198031	nicotine 7 MG/Day 24HR Transdermal System	SY	ae406389-0f83-d5c8-bd2f-56075e57453a	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0536-1108-52	00536110852	7 PATCH in 1 CARTON (0536-1108-52) / 24 h in 1 PATCH	7 patch	2026-03-20		No	No	Current
0536-1108-71	00536110871	28 PATCH in 1 CARTON (0536-1108-71) / 24 h in 1 PATCH	28 patch	2026-03-20		No	No	Current
0536-1108-88	00536110888	14 PATCH in 1 CARTON (0536-1108-88) / 24 h in 1 PATCH	14 patch	2016-04-01	0000-00-00	No	No	Current